High-profile, anatomy-specific craniofacial implants for combined hard and soft tissue reconstruction with embedded technology for medicine delivery

ABSTRACT

An anatomy-specific implant for neuroplastic surgery. The implant includes a soft tissue implant component designed within and adapted to replace or restore missing soft tissue in a skull, joint or spine of the patient, wherein the soft tissue implant component is adapted to be coupled by an interdigitated connection to a rigid component. The rigid component can be a skull implant adapted to replace missing cranial or vertebral bone, or healthy cranial or vertebral bone, either of which can have downward extending catheters for medicinal brain or spinal cord infusion to help bypass the blood-brain barrier via multiphase flow. The soft tissue implant may include a functional component having neurotechnologies such as MRI-lucent pumps, Bluetooth connection systems, refillable diaphragms, remote imaging devices, wireless charging capabilities, and/or informative biosensors. The soft tissue implant component may be interchangeable with another soft tissue implant component in plug-and-play fashion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/400,239, filed Aug. 12, 2021, which claims priority to U.S.Provisional Application 63/065,045, filed Aug. 13, 2020, and entitled“Multi-Purpose, Anatomic-Specific Implants for Combined Hard and SoftTissue Reconstruction with Embedded Technologies for Improving Form andFunction”, the entire contents of which are hereby incorporated byreference.

FIELD

The embodiments generally relate to the field of chronic medicinedelivery, refillable needle reservoirs, wearable technology,Bluetooth-enabled devices, wireless charging power platforms,state-of-the-art biotechnology, craniofacial implants, neurosurgery,neuroplastic surgery, implantable neurotechnology, plastic surgery,craniomaxillofacial surgery, orthopedic surgery and neuro-oncology, andspecifically to the field of improving form and function of permanentimplants for anatomical replacement of both hard and soft tissuecomponents.

BACKGROUND

Modern day man-made implants have been designed for anatomicalreplacement with respect to the bone (i.e., hard tissue) defects whichthey replace. For example, the present inventor has invented thelow-profile intercranial device, described in U.S. Pat. No. 11,058,541,issued on Jul. 13, 2021, which discloses placing implantabletechnologies within the hard tissue (cranial bone space) and isdescribed specifically as “an implant for which substantially conformswith a resected portion of a skull of a patient”. However, as thetechnology has moved forward with respect to miniaturization, a lessinvasive option would be to use a combined soft and hard tissueanatomical component within the temporal fossa as an improved strategyto prevent the surgeon from having to remove large segments of bone tomake room for the low-profile intercranial device. For example, thepresent invention may utilize combined soft tissue replacement therebyallowing for a small amount of bone space utilization, versus the moreinvasive option, which is using a large segment of cranial boneresection to make room for embedded neurotechnology; furthermore, softtissue space utilization may be much safer for the patient.

The present invention is pre-designed using anatomical compartment sizesmatching the typical adult male and female, as opposed to the presentinventor's prior invention, “Patient-specific Craniofacial Implants”,described in U.S. Pat. No. 10,918,485, issued on Feb. 16, 2021. Theprior invention discloses using the temporal soft tissue space incombination with the hard tissue (bone) space, but is only limited to a“patient-specific” (i.e., custom) design. In contrast, the presentinvention can use an identical temporal augmentation volume and implantdesign; however, it may be offered both in both “anatomy-specific”(i.e., non-customized) and “patient-specific” (i.e., customized)embodiments. The implants according to the present invention may eitherbe pre-designed using computer-assisted design/manufacturing (CAD/CAM)as customized, patient-specific implants, or can be pre-designed asanatomy-specific implants using anatomical averaging. The presentinvention may employ anatomical averaging to accomplish an“off-the-shelf”, one-size-fits-all implant. Embodiments of the presentinvention may partially fill some missing bone, but will also fillpartially some missing soft tissue, e.g., temporalis muscle and/ortemporal fat pad. This type of implant manufacturing process may equateto a pre-fabricated device and/or implant manufactured from a safe,biocompatible, alloplastic material which may hold a permanent shape andform with respect to time, regardless of bio-engineered internalmovements (i.e., chronic, direct, pump-assisted, medicine delivery viaseveral connected catheters extending deep to within the neighboringbrain's white matter as a way to bypass the blood-brain barrier), and/orsubsequent mechanical trauma (i.e., the outer casing shell surroundingthe medicine delivery components are designed to fit snugly within andhave internal buttressing within the hollow space for which remainsstable in the setting of inadvertent head trauma). Notably, utilizationof the soft tissue space, in addition to the cranial bone space,provides the ideal, non-obvious solution for placement at the smallestdistance away from the brain (i.e., there is no closer space to thetemporal lobe of the brain than the temporal cranial bone and temporalsoft tissue). Hence, from an engineering perspective, the design andsafety of the present invention is greatly increased given that theconduit (i.e., catheters) for medicine delivery can be made much shorterand thus the flow is much more predictable.

However, up until recently, there have been no “anatomy-specificcraniofacial implants” or devices that were pre-designed for thetemporal region with medicine pumps for convection-enhanced delivery tothe brain and/or internal biosensors for improving both form andfunction of one's head in the setting of intracranial pressure changes(i.e., hydrocephalus, bleeding, tumor growth, change in altitude,seizures, etc.), and, at the same time, strategically designed toreplace both the temporal hard (i.e., bone) and soft tissue (i.e.,temporalis muscle, temporal fat pad, and subcutaneous tissue) defectssimultaneously in a way that camouflages the device itself completelyfrom the naked eye with absent deformity. In fact, the first-ever casescenario using a bone replacement implant, with embedded biosensordesign, was surgically performed by the present inventor (Gordon C R, etal. “First in-human experience with integration of wireless intracranialpressure monitoring device within a customized cranial implant.”Operative Neurosurgery 2020 Jan. 28). In addition, the present inventorwas also the first to describe “Patient-specific Craniofacial Implants”(U.S. Pat. No. 10,639,158) for replacing both missing temporal bone andsoft tissue in the craniofacial region. However, this prior inventionwas strictly limited to a customized solution addressing a problem for ahard and soft tissue scenario, as opposed to the present invention,which is non-customized, but is rather designed based on normativevolumes applied to temporal hard (bone) and soft (muscle/fat) tissue.While a patient-specific implant is customized by a pre-operative CTscan and CAD/CAM modeling based on individualized findings, theanatomy-specific implant of present invention may be pre-fabricatedusing normative values and human atlas data to accomplish a similarresult with similar efficacy and similar effect, but with less labor orlead time needed for implant availability. Notably, the“patient-specific craniofacial implant” patented invention takes onaverage 3 days to 3 weeks to design, fabricate and deliver, where as the“anatomy-specific” design in this instance described here can bepre-fabricated well in advance and is therefore a much simpler “rightsided” or left sided” temporal implant with immediate availability, andcan be with or without the use of embedded technologies within formedicine delivery.

Bony anatomies constructing certain aspects of the human head maintain aconstant form, and thus lend themselves well to the field of implantableimplants and devices in that their shape and form stay ever-constant.For example, an embodiment of the present invention describes a devicewith a hard-shell, curved case that is internally hollowed strategicallyto support internal workings consistent with pump-assisted technologyfor brain medicine delivery. Conversely, soft tissue areas found overthe craniofacial bone, such as with the temporalis muscle, temporal fatpad, and temporal subcutaneous tissue, are constantly changing in shapedepending on one's age and/or bodily movements throughout the day, andtherefore have inconsistent boundaries challenging the task of implantdesign. As such, the use of temporal soft tissue spaces was notdescribed in the present inventor's published patent applicationentitled “Magnetic resonance imaging compatible, convection-enhanceddelivery cranial implant devise and related methods” [WO-20200006240-A1]as it was initially believed that the cranial device could be used toreplace one's skull. After further consideration, the present inventordetermined that an optimal implant design to achieve direct brainmedicine delivery requires the use of the temporal soft tissue space.Thus, the present invention may replace the normal soft tissue withinthe temporal fossa with hard-plastic devices, but with a shape thatcamouflages placement and may remove signs of visible deformity (i.e.,neuroplastic surgery practice and principles). According to thedisclosure herein, a pre-fabricated multipurpose device may bedesigned—in non-customized fashion, thereby allowing “off-the-shelf”,easy availability—via a novel design algorithm related to humannormative data (i.e., anatomical averaging) including several imagingmodalities such as computed topography (CT) scanning ormagnetic-resonance imaging (MRI). Specifically, bony landmarks andanatomical confines of the craniofacial skeleton are best understoodusing CT, and soft tissue landmarks and anatomical confines are bestunderstood using MRI. Thus, an embodiment of the temporal devicedisclosed herein may be made to simultaneously 1) replace hard and softtissue (in both pre-existing and non-existing scenarios) using theaforementioned advances by the present inventor; 2) contain embeddedtechnologies like internal electro-osmotic pumps with non-ferrouscomponents, biosensors for important wireless data collection likeinternal flow rate, systems capable of pump-assisted, multiphase flow,convection-enhanced medicine delivery, and/or embedded ultrasound arraysfor remote brain imaging using the aforementioned advances by thepresent inventor to help determine if and when recurrent brain tumorsare regrowing unaffected by the local chemotherapy delivery; and 3)using the embedded technological elements for medicine delivery toimprove form and function simultaneously so that it is not visible to anoutside party that the patient is receiving direct brain medicinedelivery and that there is a refillable diaphragm for needle puncturejust a few millimeters below the skin of the patient's scalp. Notably,in the present inventor's previous application, “Magnetic resonanceimaging compatible, convection-enhanced delivery cranial implant deviseand related methods” [WO-20200006240-A1], the cranial device wasenvisioned to be placed within the skull underneath the hair-bearingscalp. However, the present inventor has realized that the such is asuboptimal design and one that would severely challenge the healthcareprovider when and/if trying to palpate and inject medicine through thescalp. Instead, the present inventor has determined that a high-profile,temporal implant replacing both the hard and soft tissue would positionthe medicine delivery implant in the temporal region, which is ananatomical area devoid of hair, easier to locate by palpation, and mostimportantly, the medicine injection process would be less cumbersome andmore safe, free of hair and potential bacteria contamination.Furthermore, having a “high-profile” aspect of the implant (i.e.,extending through and reconstructing the soft tissue space) allows forthe device to extend just underneath the skin, which can be valuable forseveral reasons such as easier/safer access for percutaneous needleentry for medicine refilling, as well as providing a shorterdistance/less tissue interference when it comes to wireless chargingand/or Bluetooth wireless communication.

Of note, a craniofacial implant limited to the “intercranial” region,such as the present inventor's prior invention of a low profileintercranial device, fails to provide the correct access point for thistype of medicine-delivery invention. For instance, it's the extension ofthe present implant's boundaries moving outward, upward, and laterallybeyond the previously-described skull bone space (i.e., the presentimplant design now being “extracranial” instead of “intercranial”), andinstead now also replacing temporalis muscle, temporal fat, and temporalscalp subcutaneous tissue thereby reaching all the way up to just underthe temporal scalp/face skin, which in turn, provides a major differenceand benefit by now allowing a short, non-boring needle to puncture theskin safely and quickly enter the refillable valve just a millimeter ortwo below the skin—in a minimally-invasive way. In contrast, refilling a“low profile intercranial device” would be a much invasive given thatthe needle would need to transverse the entire scalp tissue all the waydown to the level of the bone-containing implant. Furthermore, the entrypoint along the temporal region—for a “low-profile intercranialdevice”—would be dangerously obstructed by the temporalis muscle, thetemporal fat pad, and the temporal subcutaneous tissue. This would causethe patient pain and bleeding each and every time the needle was used torefill the medicine port. As such, the present inventor posits that tosafely achieve medicine delivery to the brain via a simple, quick,refillable reservoir an anatomy-specific temporal implant such as thepresent invention is needed. Advantages of the present invention includeusing the temporal fossa location point and this novel temporal implantdesign as an enhanced strategy for combined hard and soft tissuereplacement thereby preventing visible deformity; providing safe accessto percutaneous needle sticks given there is only thin temporal skincovering the implant versus a full-thickness, hair-bearing scalp; and 3)provides an exponential increase in internal volume for embeddedpump-assisted technology to fit within unlike the use of the“intercranial device” space limited by human skull dimensions.

Systemic delivery of medication to the brain is hindered by theblood-brain barrier's highly selective permeability, which allows thehighly-specified passage of only certain materials from capillary bloodinto the brain's extracellular fluid with just a relative fraction ofless than 99%. In fact, recent reports state that over 60% of allpharmaceutical laboratories specific to neurologic medicine developmentare shutting down on an annual basis due to the complicated, gridlockbarriers preventing successful delivery of blood-based medicines intothe brain. As such, much work has been focused on engineering medicinalcompositions to be small and hydrophobic enough to diffuse through theendothelial cells that make up the complex blood-brain barrier. However,this has been suboptimal since many of the medicinally advantageouscompositions are simply too large or hydrophilic and cannot beengineered for such direct delivery to the brain. Thus, in 1994, Dr.Oldfield at the NIH was the world's first scientist to introduce a newmethod known as “convection-enhanced delivery” as a way to bypass theblood brain barrier and to directly convect (i.e., provide multiphaseflow) medicine from a pump through a single catheter directly into thewhite matter of the brain, so as to skip the blood vessel routealtogether (Bobo R H, Laske D W, Akbasak A A, Morrison P F, Dedrick R L,Oldfield E H. “Convection-enhanced delivery of macromolecules in thebrain”. Proc Natl Acad Sci USA. 91(6):2076-80). Oldfield and colleaguesreported first-ever success in opening the scalp and removing the skullin several cats and using a single-catheter system with a pump toeffectively convect medicine at a rate ranging from 0.5-1.0microliters/minute, as a way to successful bypass the blood-brainbarrier. Although remarkably successful, the cat could only survive for24 hours given the invasive nature, infectious risks, andextra-anatomical design constraints set for by the pump-assistedtechnology. Thus, in the neuroscience field for the last three decades,long-term convection-enhanced delivery has remained promising butunachievable in humans, as a proper anatomical positioning and spaceneeded to make room for such device implantation had not been conceived[Bruce et al. Convection enhanced delivery. Neurotherapeutics 2017;14:358-371]. Prior to the present invention, an anatomic-specific,multi-purpose design to accommodate MRI-lucent pump technology by way ofincorporating the temporal bone, temporalis muscle, and the temporal fatpad in its design algorithm has not been envisioned. In other words, onewas not able to discover a reliable method and device capable of chronic“convection-enhanced delivery” given the unique size constraints withinthe human head or skull. For instance, the present inventor's priorinvention, the low-profile intercranial device, was limited to avertical size of about 4-12 millimeters (i.e., thickness) given theconstraints of the intercranial bone space. In contrast, the presentinvention's provision of a device design compatible with combined hardand soft tissue spaces can now instead allow important high-profiledevice medicine delivery to occur within the brain and body, byproviding triple the available volume for internal housing (betweenabout 12-40 millimeters in thickness). The addition of temporal muscleand temporal fat replacement adds a several-fold increase in internalspace and thereby drastically improves the odds of safe, pump-assisted,medicine delivery to the brain, as well as provides additional space forsynergistic technologies like ultrasound probes (to detect brain tumorrecurrence) and biosensors (to detect too much or too little medicinedelivery). As such, it requires a high-profile contour that extends waybeyond the limits of the cranial bone space and should therefore betermed “extracranial” in design (i.e., as opposed to being limited tojust the “intercranial” space). By doing so, it extends all the way upto just a millimeter or two below the skin. Furthermore, with ahigh-profile configuration, it becomes easier to palpate with digitalexam so as to assist the healthcare workers in feeling around thetemporal skin for the circular diaphragm set up to receive percutaneousmedicine injection. The new temporal implant design (combining hard andsoft tissue) encompasses outward from the skull space and extendsoutward into the normal temporal muscle space, the normal temporal fatspace, and the normal subcutaneous space. This configuration increasesseveralfold the volume available for multi-purpose, embeddedtechnologies for brain medicine delivery. Furthermore, an improvedanatomical location such as this, with a novel position ofanatomy-specific, pre-fabricated devices within both the cranial bonespace and overlying soft tissue area like temporalis muscle and temporalfat, presents a newfound strategy for enhanced medicine delivery ofrechargeable battery-powered platforms capable of local neurologicalmedicine delivery would be a welcome addition to the art. For example,with more space, the possible of having larger rechargeable batteryplatforms comes to life. And because of this volume increase, thepatient's charge cycle can switch instantly from needing a 1 hour chargethree times a day (i.e., every 8 hours) to needing a 1 hour charge everythree days—which is a major difference for the neurosurgical patientreceiving localized brain medicine delivery and drastically changes therisk of non-compliance (i.e., more room inside equates to betteraccommodation for larger battery sizes). Also, the advance here isutilization of the combined hard and soft tissue space for embeddedtechnologies within a pre-fabricated implant made by way ofanatomical-averaged, CAD/CAM design—so that when a patient presents withan unexpected brain tumor and new onset seizures, there isn't a wait ofseveral days or weeks to customize the implant design. The presentinvention can allow hospitals to stock anatomy-specific temporalimplants for combined soft and hard tissue reconstruction on theshelves, a brain tumor patient undergoing tumor resection and craniotomycould have this implant placed in one surgery—instead of two surgeries.For instance, the temporal fossa and the temporal soft tissue normallyaverage 22 to 24 cubic centimeters (as published by the present inventorin his article entitled “Quantitative analysis of dual-purpose,patient-specific craniofacial implants for correction of temporaldeformity” Neurosurgery 2015 PMID 25710104), and thus, the presentinventor has leveraged his clinical expertise and knowledge base todesign a multi-purpose anatomy-specific device to fit snugly within thisalluded space; consequently, the implant of the present invention mayhave about 65-70 cubic centimeters of volume, which is nearly two orthree times as much volume when using only the cranial bone space. Inaddition, the anatomical placement of this technology above the skull—asopposed to being limited to within the skull—is both advantageous forthe device engineer looking to include within many different components,easier to fill with a transcutaneous needle (given that the top edgeextends upward to the skin as opposed to staying deeper at the bonelevel), and less invasive and easier for the surgeon to implant.Consequently, the functional component may be considered “high-profile”,in that it has at least a portion thereof extending outwardly from thebone level towards the skin, or, in other words, above the skull.Similarly, local medicine delivery requires that the refillablediaphragm be snugly positioned just under the skin for easy needlepenetration, and that means that placing the device within the softtissue space is advantageous in comparison to only placing the devicewithin the skull and having a thick scalp above (i.e., a thick scalpwith bacteria-laden hair would interfere with the needle penetrationsystem which is critical in allowing monthly refills of neurologicmedicines for chronic brain disease management). In parallel, thepresent invention may further be applied to tumor areas other than justthe brain. For example, the device of the present invention may bepositioned above the chest/ribs and utilize the bone (hard tissue) andpectoralis muscle (soft tissue) combined tissue space to be safelymaintained in a place that allows for pump-assisted medicine delivery tothe lung for instances needing chronic pump-assisted infusion like lungcancer or chronic infection like pneumonia. Similarly, the presentinvention could also be positioned along the lower bony ribs and rectusabdominus muscle (as a combined hard and soft tissue space) to allowplacement for solid organ cancer chronic infusion, for example in caseof liver cancer or hepatitis treatment. Yet another combined hard andsoft tissue area may include the spine (hard) and paraspinous muscles(soft) as a combined space for device placement allowing direct,pump-assisted medicine delivery for the spine (i.e., anti-pain,anti-tumor) and/or orthopedic joint areas like the hip, knee, shoulderand ankle for chronic pain medicine infusion or cancer. Thus, a conceptof using the bone and soft tissue space for local brain medicinedelivery via convection-enhanced pump mechanisms could be translatedover to other anatomical areas requiring combined hard and soft tissuereconstruction and localized medicine delivery. Again, the limits ofstrict bone replacement (as previously described by the present inventorin U.S. Pat. No. 11,058,541, entitled “Low-profile Intercranial Device”and in published application WO-20200006240, entitled “Magneticresonance imaging compatible, convection-enhanced delivery cranialimplant devise and related methods”) present further challenges ofconfined space during design, and thus limits both the amount of storedmedicine within, the space for embedded wireless charging technology andbattery storage, and the size dedicated to pump-assisted technology. Byexpanding the implant design and its footprint within the human skulland extending outside the normal bone boundary to include theneighboring temporalis muscle, temporal fat and temporal subcutaneoustissue, more room for brain medicine delivery is available, which wouldequate to less periodic fills needed (more room for long-term medicinestorage and larger reservoir), more room inside allows for a largerenergy storage platform via RF charging, safer wireless battery charging(i.e., an implant with an extension closer to the skin level means lesstissue interference with regards to the embedded, wireless chargingmechanism), and better patient satisfaction.

For example, during brain tumor craniotomy surgery for recurrentglioblastoma disease and need for repeated resection, one would bechallenged in placing a standard MRI-compatible device within the head.This is because any device within a brain tumor patient must not just beMRI-safe and/or MRI-compatible (defined as absent ferrous-containingmaterial), but more importantly, it should be considered MRI-lucent,distinct from being merely MRI-safe and MRI-compatible. As used herein,“MRI-lucent” means that the device can sit within the temporal fossa, ina combined space of hard and soft tissue just a few centimeters awayfrom the brain and the previous brain tumor location, and be relativelyinvisible (i.e., radio-lucent) to the MRI machine in charge withidentifying brain tumor recurrence on periodic scans every 3-4 months,(i.e., the present invention provides zero radiologic artifact). Thepresent inventor has posited that, to a malignant brain tumor patientfor whom is getting monitored every 90-120 days for brain tumorrecurrence, it is imperative that their combined, multi-purpose deviceis not only MRI-compatible in design, but is also MRI-lucent. Forexample, in PCT application PCT/US2019/039519, entitled “Magneticresonance imaging compatible, convection enhanced delivery cranialimplant devices and related methods”, the present inventor described theimplant being MRI-compatible. However, for the present invention, thedevice within the combined soft and hard tissue space is not merelyMRI-compatible, but is rather enhanced in its design so as to beMRI-lucent”—which is a major advance for neurosurgical patients withchronic brain disease requiring meticulous MRI surveillance, such aswith glioblastoma and malignant brain tumors. This may be accomplishedby avoiding the use of electroactive polymers, and to instead use anelectro-osmotic pump full of simple water (or equivalent). Hence, it'sthe electroactive polymers (EAPs) that may cause artifacts and therebyinhibit proper monitoring of the brain tumor patient receiving chronicmedicine delivery. Additionally, in the aforementioned application, thepresent inventor described placing the device within the skull space,which he has now determined as being too limiting when it comes tobuilding pump-assisted devices for brain medicine delivery and bypassingthe blood-brain barrier. In contrast, the present invention remedies thedeficiencies of the present inventor's prior patents and patentapplications that are described herein. One, the device of the presentinvention is non-patient specific, and instead anatomy-specific. Second,the device of the present invention does not need to stay within theskull space like a L.I.D., and instead is placed within a combinedanatomical space incorporating both cranial muscle/fat and cranialbone—thereby allowing the engineers much improved volumes forpump-assisted technology within. With this additional space, theengineering team can use non-ferrous materials unlike before whenworking in space-limited implants occupying the cranial bone space. Theengineers are now removed from design constraints and much moresuccessful in building device components absent of any iron and/orartifact-causing materials. Third, the device of the present inventionincludes an MRI-lucent design which removes radiographic artifactsaltogether, and instead uses an electro-osmotic pump (or equivalent)rather than an electroactive polymer (i.e., replacing MRI-opaque gelswith MRI-lucent water).

The present invention may also find applications in chronic neurologicaldisease states like neurodegenerative disease (i.e., Alzheimer's,Parkinson's), medicine-resistant epilepsy, neurotrauma/paralysis, majordepression, schizophrenia, bipolar disease, ADHD in children, braindysfunction (i.e., paralysis), brain related age-changes (i.e., memoryloss), and post-traumatic stress disorder. Also, future options mayinclude stem cell injections via this device for enhanced brain recoveryfollowing traumatic brain injury, cancer or stroke, as well asbrain-enhancing medicines or supplements that could increase one'smemory, athletic performance, balance, hand-eye coordination,brain-computer interface, and/or high-stress situation performance(military, police, etc.)

For placement, the surgeon may remove any and all diseased or damagedportions of the skull (craniectomy defects), or may electively removenormal bone to make room, while the brain is exposed underneath withoutinjury. In addition, as the normal temporalis muscle and temporalis fatshrinks after previous craniotomy (i.e., post-craniotomy temporal softtissue hollowing), there will be extra volume in which the device of thepresent invention can be placed—as opposed to the normal, pre-operativevolume of the muscle and fat. Therefore, a combined hard and soft tissuereconstruction temporal implant with medicine delivery capabilities canfacilitate bypassing the blood-brain barrier, and further, due to itsdesign and reconstructive aspect, can restore the soft tissue volumeback to its pre-operative state. This phenomenon of “soft tissuetemporal hollowing” is related to deinnervation and/or devascularizationof the temporal soft tissue during standard pterional craniotomy for abrain tumor. Hence, when the surgeon comes back for revision surgery,the muscle and fat need some type of implant reconstruction (i.e.,augmentation), wherein the device of the present invention may be used.The present device not only provides more internal volume, but alsoserves as a reconstructive option for brain surgery patients wishing tocorrect and/or prevent temporal hollowing deformity. Following resectionof this diseased cranial bone (either in a “multi-staged” fashion withone surgery completed ahead of time for bone removal prior to implantplacement, or in a “single-stage” fashion where the implant is placed atthe same time of removal), such craniectomy defects are oftenreconstructed with custom craniofacial implants (CCIs)—as opposed tousing generic, “off-the-shelf” materials which currently fail to provideany true anatomical replacement. Historically, however, cranioplastypatients requesting CCI-based reconstruction for an ideal appearancewere limited to “second-stage” operations in instances of pre-existingskull defects so that the exact fit and design could be obtained.However, recent modifications by the present inventor haverevolutionized the field of skull replacement surgery and is termed“single-stage cranioplasties”—by which a clinician, such as aneuroplastic surgeon or neurosurgeon, manually reshapes/resizes apreviously-ordered, custom implant (with oversized dimensions) to fitperfectly into the skull defect as true anatomical replacement—asopposed to using an “off-the shelf” material for which only partiallyrestores the missing bone. Either way, for single-stage methodsinvolving skull tumors or second-stage cranioplasties for pre-definedskull defects, the advent of computer-aided design/manufacturing(CAD/CAM), has provided surgeons alike with perfectly-shaped CCIsdesigned and manufactured based in part on fine cut preoperativecomputed tomography (CT) scans and three-dimensional reconstruction(+/—stereolithographic models). However, present day challenges do notlimit themselves to just missing cranial bone. A new invention is nowneeded to use CAD/CAM designing for anatomy-specific implants capable ofreplacing both hard (bone) and soft tissue (overlying muscle and fat),given that the present inventors advance of embedded technologiesrequires a larger footprint (i.e., to fit Bluetooth modules, wireless RFcharging units, microprocessors, MRI-lucent pump technology, real-timebiosensors, imaging arrays with ultrasound crystals, etc.) and dockingstation to truly advance the field. Such temporal devices may havewireless charging platforms developed to be fully MRI-safe, in specificareas like charging with radio-frequency (RF) signals instead of thestandard, MRI-adverse, magnetic coils used in commonly found householddevices and cellphones. Such multi-purpose devices may also have aBluetooth, wireless connection and enhanced security design withextensive threat modeling to prevent biohacking and abnormal medicinedelivery rates. Such devices may also have within a computer chip andinternal processor to help self-guide ideal flowing of the pump-assistedmechanism. Such devices may have a small computer chip capable ofconstant monitoring a flow rates through each of the 4-5 catheterspumping medicine into the brain, so as to self-detect, overcome, andaccommodate unexpected scar tissue or increased resistance to flow inany one or more catheters at any time. Such a novel constant monitoringmechanism disposed within the temporal implants so that each catheterpumping medicine into the brain can continue a steady flow around0.5-1.0 microliters/minute, regardless of how much resistance is locatedat the catheter-brain interface. Scar tissue, radiation changes, and/orrecurrent brain tumor disease can all negatively affect the flow ratesexiting each of the embedded catheters. Hence, the newfound extra spacewithin this hard and soft tissue implant now allows the engineers toincorporate additional safety mechanisms such as “cruise-control flowrates” by embedding several biosensors along the fluid circuit. Suchdevices may also have remote biosensors to detect abnormal fluidaccumulation around the brain requiring immediate medical attention andmobile messaging. For instance, the normal intracranial pressure isaround 5-15 mmHg, and so any increased pressures from fluidextravasation or implant malfunction requires immediate detection; withthe additional space herein, the extra technology has room to now beincorporated. Such devices may also have miniature ultrasound arrayshoused within the bottom of the device, facing the brain, that may useartificial intelligence to self-monitor the brain tumor cavity for anygrowth changes related to recurrent tumor and/or irradiation-inducedscar tissue. Such devices may also have a palpable, “high-profile”,diaphragm located just a millimeter or two below the temporal scalp'sskin, as a safer entry point capable of around 1000 repeatedtranscutaneous needle sticks (through the scalp) using a specialnon-boring needle and material design preventing any type of accidentalleakage (especially since the filling of chemotherapy is very dangerousand caustic to the surrounding skin). Such devices may have a smallcomputer chip capable of “cruise-control” to allow constant monitoring aflow rates through each of the 4-5 catheters pumping medicine into thebrain, so as to self-detect, overcome, and accommodate unexpected scartissue or increased resistance to flow in any one or more catheters atany time. Such devices may have a mobile app capable of sendingreal-time, patient-protected data to the patient, patient's family,and/or patient's healthcare providers—with critical information such asmedicine storage amounts, data with respect to flow rates, etc. Suchdevices may also one day have internal suction capabilities in that theycan self-withdraw fluid from the diseased brain along with cells forbiopsy and diagnosis, all of which can be accessed via a smallsubcutaneous port—simply by reversing the flow of the MRI-lucent pumps.

As discussed herein, prior inventions by the present inventor were onlylimited to the bone space; currently, recent investigations by thepresent inventor reveal that components like MRI-lucent batteries,computer chips, catheters, biosensors, pumps, Bluetooth modules, RFcharging components, radio antennas, etc., all require morethree-dimensional space prior to the present inventor's originalconcepts. As such, one needs to advance the field by pre-fabricatingcombined soft and hard tissue temporal implants with bigger footprintsto house powerful, life-changing technologies unlike ever before. Thus,the field of solid bone replacement for neuroplastic surgery,neurosurgery, neuro-oncology and craniofacial surgery could greatly beimproved by changing the design confines to include some of thesurrounding soft tissue (i.e., temporalis muscle, temporal fat pad, andtemporal scalp subcutaneous tissue), to provide an additional footprintfor the use of embedded technology like biosensors, medicine delivery,or remote imaging within multipurpose, anatomy-specific implants.

In parallel to skull replacement, joint replacement by orthopedicsurgery since the 1960's has also enjoyed overwhelming success byreplacing bone defects with disease such as osteoarthritis and cancer ina way that forever improved restoration of form and function. However,orthopedic-style implants are only designed to replace bone like jointsinvolving the hip, knee, shoulder and ankle. No consideration has beengiven to capitalizing on the surrounding soft tissue space—either inorthopedic surgery or in this implantable neurotechnology space.Furthermore, these bone-only implants (both off-the-shelf andpre-fabricated) are solid inside with no embedded function. Thus, thefield of solid bone replacement for orthopedic joint surgery couldgreatly be improved by changing the design confines to include some ofthe surrounding soft tissue, to provide an additional footprint for theuse of embedded technology like biosensors, medicine delivery, and/orremote imaging.

In parallel to skull replacement, spine surgery for various diseaseslike trauma, paralysis and/or cancer have experienced much success usinghard-tissue implants designed for missing vertebrae (bone elements ofthe spine). However, spine surgery-style implants are only designed toreplace bone-like structures like the vertebrae and/or pelvis. Noconsideration has been given to utilizing the surrounding soft tissuespace—like the paraspinous muscle, which is quite similar to thetemporalis muscle in this regard. Furthermore, these bone-only implants(both off-the-shelf and pre-fabricated) are solid inside with noembedded function. Thus, the field of solid bone replacement for spinesurgery could greatly be improved by changing the design confines toinclude some of the surrounding soft tissue, to provide an additionalfootprint for the use of embedded technology like biosensors, medicinedelivery, Bluetooth connectivity, wireless charging, and/or remoteimaging.

In fact, recent journal publications suggest that the use of CCIsdesigned by the present inventor with dual-purpose (“Zhong S, Huang G J,Susarla S M, Swanson E W, Huang J, Gordon C R. Quantitative Analysis ofDual-Purpose, Patient-Specific Craniofacial Implants for Correction ofTemporal Deformity. Neurosurgery 2015 June; 11(1):220-9) can betterpreserve post-neurosurgery appearance, prevent post-operative deformitywith accompanying social stigma, decrease total operative times, preventscalp-related wound complications, and enhance patient satisfaction—andtherefore, they serve as an ideal medium for reconstructing neurosurgerypatients. This major advance was accomplished by using a novel designalgorithm provided by the present inventor which capitalized on theunder-utilized hard and soft tissue space around the brain (therebyerasing the old, outdated, generational dogma that cranial implantscould and should designed for the anatomical bone space only)—and howthis new advance could be reliably accomplished using pre-operative,CAD/CAM design. However, at the time, there was no computer-aidedsurgery technology available to guide the surgeon in performing“single-stage bone replacement of the skull”, other than by hand-carvingthe implant intra-operatively with simple eye-hand coordination andcommon-day burring. Thus, the present inventor worked diligently todesign and invent a technology to provide the surgeon real-time,computer-guided information for streamlined size modification. Hence, inU.S. Pat. No. 10,448,956, entitled “Computer-Assisted Planning andExecution System” and U.S. Pat. No. 10,603,175, entitled “CuttingMachine for Resizing Raw Implants During Surgery”, the present inventordescribed a recently-developed surgical workstation with the novelability to provide intraoperative visual guidance related toplanned-versus-actual position of CCI (on intraoperative visualmonitors)—following placement of the CCI within the three-dimensionalcraniofacial defect (in relation to virtual plan)—which ultimately addseven greater precision and simplicity to this complex operation.Notably, this CCI-related technology—both computer-assisted androbot-assisted—could be employed for just bone-replacement design orcombined hard/soft tissue, dual-purpose design. Regardless, all CCIs upuntil recently were used to replace abnormal bone having some form ofdisease, either of benign or malignant etiology. Thus, these customizedskull implants were termed “static CCIs” (SCCIs)—mainly because theirmain constant purpose (i.e., unchanged purpose with respect to time)encompasses strictly two benefits following placement—“brain protection”and “enhanced appearance”. Therefore, in the past, the present inventordescribed a novel solution to “static” or “non-functioning” implants forbone replacement—as way to improve the field—by way of introducing theLow-profile Intercranial Device (L.I.D.), which describes strictly bonereplacement with embedded technologies (mainly the cranium). There, theterm “intercranial” was used, so as to illustrate the technology beingconfined to the bone-only space. However, the present inventor's recentefforts have shown this to be disruptive and rate-limiting when it comesto achieving successful chronic brain medicine delivery to help bypassthe blood-brain barrier. Now, the present day inventor is advancing thefield further by describing the limitations of “static” or“non-functioning” patient-specific and anatomy-specific craniofacialimplants with dual-purpose design—replacing combined hard and softtissue defects, and by drastically extending the confines of theirdesign away from “intercranial” and towards “extracranial” instead.Hence, the present invention is directed towards multi-purpose,anatomy-specific implants for combined hard and soft tissuereconstruction with embedded technologies for improving form andfunction.

Meanwhile, there are many FDA-approved, “off the shelf” technologiesthat have life-changing or life-saving functionality. Specifically, inneurosurgery, there are technologies capable of delivering electricalimpulses (i.e., epilepsy management), pumping neurological medicines(i.e., chronic pain), or syphoning/diverting excess cerebrospinal fluidwith programmable shunt valves (i.e., hydrocephalus management), butaren't customizable or designed to protect the brain. However, each ofthese neurotechnology implants—supplying intermittent or ongoinginteraction with the central nervous system in some capacity—have alarge, irregular footprint and suboptimal shape design incompatible withthe principles of neuroplastic surgery—whose mission is to optimize bothform and function. Similarly, the same exact design setbacks could besaid for revolutionary technologies in orthopedic and spine surgery.Many revolutionary technologies are placed in patients with chronicpain, debilitating disease and/or tumor disease along the spine, pelvis,and joints, but the design flaws accompanying these technologies leadsto visual deformities and high-rates of extrusion due to theincompatible shapes and failure to respect to the anatomical boundariesof the overlying soft tissue (i.e., muscle/fat). Again, such embeddedneurological implants do not fall into the normal anatomical barriers ofthe scalp or skull and therefore cause risk by impinging neighboringtissues and visual deformity. If the implant is above the skull andpoorly shaped, then it equates into premature extrusion and prematureremoval. If the implant is bulky and placed under the skull, it equatesto cortex impingement and focal symptoms related to brain impingement.Thus, for the field of implantology and embedded technologies to greatlyadvance together, the present invention may 1) incorporate hard and softtissue boundaries into both pre-customized and non-customized,anatomical-specific, designs and 2) by adding additional soft tissuespace into the bony implant CAD/CAM designing, subsequently provide theembedded technology more room (i.e., severalfold) for encapsulation andlong-term safety. As such, modern day neurologic devices (brain, spineand orthopedic implants alike) will no longer be confronted andchallenged with high extrusion and infection risk (i.e., current flawsin modern day devices leads to high incidence of pain and extrusionthrough overlying skin thereby requiring premature explantation)approaching an incidence of roughly 50%. Similarly, battery-powered,low-profile devices for intercranial placement within specific anatomictissue planes along the bone space only were subsequently described inthe present inventor's issued patent directed towards low-profileintercranial devices (LIDs). In parallel, the fields of neurosurgery,neuroplastic surgery, and orthopedic surgery have been hampered andlimited in many critical areas needing improved implant delivery,including examples like battery-powered neuromodulation/corticalstimulation for epilepsy/movement disorders, valve-devices forhydrocephalic disease, pump-assisted local delivery of neurologicalmedicines for brain tumors, revolutionary spine implants for spinal cordinjury monitoring/treatment, and chronic pain related to jointosteoarthritis. One of the reasons being that the bone space—and currentday implant design—is not always big enough to accommodate thelife-changing, life-enhancing, or life-saving technology modalities andso extrusion, infection, and pain are staggering high thereby limitingsuccessful outcomes—and hence, a new invention with a much largerfootprint—and one that is anatomically-sensitive by respecting theboundaries of the normal soft tissue envelope—is unquestionably needed.For instance, the novel pump-assisted design incorporatingelectro-osmotic contents, Bluetooth chips, integrated biosensors, RFcharging platforms, and refillable medicine reservoirs, for are all nowcapable of being purely MRI-lucent, together require a significantfootprint and one that is not compatible with bone-only designs.

Additionally, there is a long-sought need for a two-piece,multi-purpose, anatomic specific implant. The first purpose of such adevice is to restore rigidity and structural integrity to the missing orreplaced bone. In reverse, having a weak, soft outer case would bedangerous for the brain surgery patient. Next, such a device may replacethe missing volume of hard and soft tissue to correct and/or preventvisible contour deformity. In addition, by extending up past the boneboundary and up closer to the skin, such a device may allow theBluetooth module/wireless charging battery to have less soft tissueinterference and/or allow the refillable reservoir to be less deep fromthe skin surface and therefore easier for the doctor or nurse to fillthe refillable medicine chamber with a special non-boring needle.Lastly, such a device with “high-profile contour” may utilize theenlarged neighboring spaces of hard and soft tissue to provide the fielda novel solution given that there is less tissue obstruction to theoutside world, which is critically important when it comes to wirelesstechnology. Furthermore, the design of such a device can be uniquelyenhanced in future iterations by offering the surgeons an integrated orindependent soft tissue implant component adapted to replace or restoremissing soft tissue in “plug-and-play” fashion as many patients age withchronic disease, that may often change with respect to time. Of note,this approach is different from the previous inventions described by thepresent inventor related to patient-specific craniofacial implants (U.S.Pat. No. 10,639,158). In contrast to those, the soft tissue implantcomponent can now be physically adapted and coupled—in a way analogousto interdigitation of a lock and key, thereby preventing micromotionand/or leakage of fluid—to a rigid base component replacing the resectedor missing bone (i.e., cranial bone, spine/vertebral bone, and jointbone). For example, this would be helpful in brain tumor patients forwhom need to switch over to a different chemotherapy drug as the cancerchanges its cellular composition and aggressiveness for recurrence.Thus, the rigid base component thereby includes a skull, spine ororthopedic joint implant adapted to replace missing bone or healthy bonefor which needs removal and immediate (i.e., “single-stagereconstruction”). Again, the hard tissue component with theskull—housing the catheters extending downward into the brain—would notneed to be moved or changed, thereby increasing the safety of theprocedure. The novel, “plug-on” soft tissue implant is designedpre-operatively on standard anatomical averaging or with CAD/CAM designconcentrating on the anatomical boundaries of the overlying soft tissue,which, in both instances, provides newly discovered volume to includeembedded technologies of various function for which may providelife-enhancing, life-changing, and/or life-saving drug deliverymodalities unlike before. Another application of this unique “plug-in”design could be the switching out of a non-functioning battery orcomponent. Specifically, the soft tissue implant component may beinterchangeable with another soft tissue implant component inplug-and-play fashion to allow rapid changing of medicine reservoirs orbiosensing or imaging hardware or rechargeable batteries, if and whenthe previous therapy is no longer needed. For instance, neuromedicinecontainers having a standardized shape may be provided, allowing for a“plug-and-play” design facilitating easy replacement of the container,and allowing the functional component to be medicine-agnostic.

But with increasing experience popularized by the present inventor andnow surgical complication rates exceedingly low, CCIs are being moreoften modified in real-time for scenarios where more or less skull boneis removed and the skull defect dimensions do not match up perfectly tothe pre-fabricated CCI (versus an originally envisioned, for example, asdesigned in a planning stage)—including such associated methods ofmaking the CCIs are described in U.S. Pat. No. 10,603,175, entitled “ACutting Machine For Resizing Raw Implants During Surgery” employingrobot-assisted technology, U.S. Pat. No. 10,835,379, entitled “Methodfor Performing Single-Stage Cranioplasty Reconstruction with a ClearCustom Cranial Implant” employing a translucent color and enhancedvisibility for on-table manipulation and tracing over irregularly-shapedskull defect, and U.S. Pat. No. 10,448,956, entitled “Computer-AssistedPlanning and Execution System” employing computer-assisted technology tomodify and enhance placement of the skull implant with intra-operativenavigation. Of note, the present inventor recently introducedsingle-stage cranial implant reconstruction by way of clear-colored,translucent implants—thereby allowing an ability to see through theimplant in real-time as a way to minimize challenges associated withmarker pen tracing. However, this clear-colored cranial implant was onlydescribed as replacing missing cranial bone. Hence, the field ofreconstructive surgery needs a clear-colored implant for which replacesboth hard (i.e., cranial bone) and soft tissue (i.e., muscle/fat)anatomies for the purpose of embedding technologies within. Similarly,the present inventor described using a clear-colored implant tofabricate the device described in U.S. Pat. No. 11,058,541, entitled“Low-profile Intercranial device”. However, again, this device wasconceived to only fill the “intercranial” space and failed to includedesign alterations and strategies to successfully include a combinedhard and soft tissue replacement strategy for chronic brain medicinedelivery. Hence, the field needs a clear cranial implant with“extracranial” design and one with a “high-profile extension” so as toallow easy, safe percutaneous needle entry (versus a “low-profile”design which impairs utility with respect to medicine delivery and userpalpability of the skin-covered access point).

Due to the recent reductions for time needed to design, fabricate andimplant CCIs, more cranioplasty procedures with alloplastic implants arebeing performed around the world than ever before—but the limitingfactor is that they strictly replace missing bone that can bepre-defined on pre-operative imaging. Until most recently, these cranialimplants were opaque in color and provided the surgeon zero visibilityto the brain and surrounding structures underneath. The present inventorthus spent significant effort in developing both computer-assisted (U.S.Pat. No. 10,448,956 “Computer-Assisted Planning and Execution System”)and robot-assisted technologies (U.S. Pat. No. 10,603,175 “A CuttingMachine for Resizing Raw Implants During Surgery”) to help circumventthese obstructive limitations and labor-intense efforts accompanyingintra-operative size modification of opaque-colored bone-replacementimplants. Accordingly, these recent developments in CCI sterility, shapedesign, and streamline production, and color—together provide anopportunity that extends CCI-based cranioplasty beyond only patients whorequire replacement of pre-existing craniectomy defects. Notably, recentadvances by the present inventor now show that opaque-colored cases maybe preferable for medicine-delivery devices versus those that areclear-colored. For example, from a sales perspective, a company mayprefer that the surgeon customer base not be able to see all componentsinside, and thus, having an opaque case may have a strategic businessadvantage. In addition, certain design elements within may be alteredwith respect to visible light, and hence a clear-colored case could bedetrimental to long-term function. Therefore, what is needed in the art,are new pre-fabricated, anatomy-specific and/or customized implantabledevices with high-profile contours which replace both hard and softtissue simultaneously (i.e., to avoid soft tissue-related complicationsand high extrusion risk leading to premature explanation like in jointsurgery, spine surgery, and neuro-cranial surgery). What is also neededin the art are corresponding methods of making and implanting suchimplant devices, including methods using computer-assisted and/orrobot-assisted surgical procedures, as described by the presentinventor. For instance, placement of these combined soft and hard tissuereconstructive implants within the human skeleton could be betterenhanced by way of robotic platforms and/or computer-guidance, as wellas the outwardly extending portions such as brain-implanted cathetersfor medicine delivery. Such improvements would exploit the benefits ofdirect access to the brain, spinal cord, or joint area and idealanatomical location/proximity provided by these novel CCIs— being placeddirectly on top and just a few millimeters away from the central nervoussystem (brain and spinal cord) and critical nerve structures (variousjoint locations like shoulder, hip, knee and ankle) to deliverlife-changing interventions provide an unprecedented method to deliverlocally. For example, robotic and computer-assisted technologies wouldenhance hard and soft tissue placement of neurologic deep brainstimulators, neurologic medicine delivery systems such as presentedhere, neuromodulation devices, imaging devices, radiation therapydevices, and remote sensing/monitoring devices. Again, by adding a softtissue extension to each bone implant design, the field now experiencesa much overdue supply of additional volume to work with, and one that issafe since it follows the soft tissue anatomical limits found onpre-operative imaging like CT scanning or MR imaging (particularly, softtissue windows). This is a much-improved approach, as opposed to placingsimilar functional devices either above or below skull, spinalvertebrae, or bony joint in non-anatomical locations, which is thestandard, suboptimal method employed currently by neurosurgeons andorthopedic surgeons alike. Furthermore, the present inventor's U.S. Pat.No. 11,058,541, issued Jul. 13, 2021 and entitled “Low-profileIntercranial Device”, the disclosure of which is incorporated herein byreference in its entirety, provided improvement in using the pre-definedanatomical boundaries of the cranial bone only to design customizedimplants (hence, the use of the adjective “intercranial”). Embodimentsof the present invention, however, use a further improved design andshape by incorporating the implant to also fill-in the overlying softtissue (i.e., “extracranial”—either as a dual-purpose, anatomy-specificimplant replacing bone and soft tissue, or as an isolated implant onlyfilling in soft tissue (for isolated cases where the bone defect issmall, non-existent due to disease, or not needed secondary toconsolidated footprint size). Lastly, both the central and peripheralnervous system is encased by bone along the skull, spine, and jointspaces—as well as hearty soft tissue in the scalp, back and surroundingjoint areas. Therefore, such a multi-purpose, anatomy-specific implantwould further optimize its utility, safety, design constraints, andultimate placement by a novel way of utilizing newfound soft tissuespace abutting the bone. Furthermore, a two-piece design (whether fusedvirtually and fabricated as a single implant, or created as two-piecesand fitted together intraoperatively by the surgeon) allows the outerpiece to employ a “plug-and-play” type arrangement forneurosurgical/orthopedic patients who need a different functional devicehoused withing their head or spine or joint space—one that could easilyswitch out depleted medicine reservoirs/batteries/components or thosewhere the type of medicine/battery needs to be changed, full memorychips no longer capable of capturing biosensor or imaging data, and thelike. Thus, a first part employing the bone space may remain constant,while a second part employing the soft tissue space may be exchanged andaltered as desired by minor surgery. By having an interchangeable softtissue component, the procedure to switch out “soft tissue implants”becomes much less invasive and better tolerated by each patient—giventhat removal of cranial bone in the head requires a craniotomy with riskof stroke/bleeding/seizure and highly-invasive surgery, removing bonealong the spinal column or joint space requires complex spine/limbsurgery with risk of paralysis, decreased mobility, pain, etc. Hence, itis in the best interests of both the patient and the surgeon to leavethe hard-tissue component undisturbed, and to only switch out the softtissue component when and if indicated.

SUMMARY

According to at least one exemplary embodiment, a high-profile,anatomy-specific craniofacial implant for combined hard and soft tissuereconstruction with embedded technology for medicine delivery isdisclosed. The implant may be adapted to fill hard and soft tissue spacewithin the temporal area. The embodiments disclosed within can includean extended “high-profile”, soft tissue component, having disposedtherein a functional component having at least one catheter for deliveryof medicine to the brain. The implants of the embodiments disclosedherein may non-patient-customized, but rather anatomy-specific, and maydesigned, for example, by CAD/CAM or non-customized, anatomicalaveraging design. The functional component may be disposed in the softtissue component, thereby utilizing the overlying soft tissue space, fordirect, chronic, pump-assisted, multiphase medicine delivery to thebrain by bypassing the blood-brain barrier. Additionally, the softtissue implant component adapted to replace or restore missing softtissue may be replaceable or interchangeable in a “plug-and-play”fashion. Accordingly, the soft tissue implant component may be adaptedto be coupled by a lock-and-key connection to a rigid componentreplacing the resected or missing bone. The functional component mayfurther have a refillable reservoir having a diaphragm capable ofrepeated penetration by needles through the skin above or Bluetoothmodule/battery platform extending up to just underneath the skin. Therigid component can be a skull, spine or orthopedic joint implantadapted to replace missing bone, or healthy bone which needs removal andimmediate, “single-stage reconstruction”. The soft tissue implant mayinclude embedded neurotechnologies of various function for which providelife-enhancing, life-changing, and/or life-saving modalities. The softtissue implant component may be interchangeable with another soft tissueimplant component in plug-and-play fashion if and when the previoustechnology is no longer needed.

BRIEF DESCRIPTION OF THE FIGURES

Advantages of embodiments of the present invention will be apparent fromthe following detailed description of the exemplary embodiments. Thefollowing detailed description should be considered in conjunction withthe accompanying figures in which:

FIG. 1 shows a first exemplary embodiment of a multi-purpose implant,applicable to the cranium.

FIG. 2 shows a second exemplary embodiment of a multi-purpose implant,applicable to the cranium.

FIG. 3 shows a third exemplary embodiment of a multi-purpose implant,applicable to the cranium.

FIG. 4 shows a fourth exemplary embodiment of a multi-purpose implant,applicable to the cranium.

FIG. 5 shows a fifth exemplary embodiment of a multi-purpose implant,applicable to the cranium.

FIG. 6 shows a sixth exemplary embodiment of a multi-purpose implant,applicable to the cranium.

FIG. 7 shows a seventh exemplary embodiment of a multi-purpose implant,applicable to the spine.

FIG. 8 shows an eighth exemplary embodiment of a multi-purpose implant,applicable to the spine.

FIG. 9 shows a ninth exemplary embodiment of a multi-purpose implant,applicable to the spine.

FIG. 10 shows a tenth exemplary embodiment of a multi-purpose implant,applicable to the spine.

FIG. 11 shows an eleventh exemplary embodiment of a multi-purposeimplant, applicable to the spine.

FIG. 12 shows a twelfth exemplary embodiment of a multi-purpose implant,applicable to the spine.

FIG. 13 shows a thirteenth exemplary embodiment of a multi-purposeimplant, applicable to the cranium.

FIG. 14 shows a fourteenth exemplary embodiment of a multi-purposeimplant, applicable to the cranium.

DETAILED DESCRIPTION

Aspects of the invention are disclosed in the following description andrelated drawings directed to specific embodiments of the invention.Those skilled in the art will recognize that alternate embodiments maybe devised without departing from the spirit or the scope of the claims.Additionally, well-known elements of exemplary embodiments of theinvention will not be described in detail or will be omitted so as notto obscure the relevant details of the invention. Further, to facilitatean understanding of the description discussion of several terms usedherein follows.

As used herein, the word “exemplary” means “serving as an example,instance or illustration.” The embodiments described herein are notlimiting, but rather are exemplary only. It should be understood thatthe described embodiments are not necessarily to be construed aspreferred or advantageous over other embodiments. Moreover, the terms“embodiments of the invention”, “embodiments” or “invention” do notrequire that all embodiments of the invention include the discussedfeature, advantage or mode of operation.

Furthermore, the present application refers to technologies developed bythe present inventor and disclosed in U.S. Pat. No. 10,639,158, issuedMay 5, 2020 and entitled “Patient-specific craniofacial implants” andU.S. Pat. No. 11,058,541, issued Jul. 13, 2021 and entitled “Low-profileIntercranial Device” and “Magnetic resonance imaging compatible,convection-enhanced delivery cranial implant devise and related methods”[published, WO-20200006240-A1], the disclosures of which areincorporated herein in their entireties. As used herein, a“multi-purpose implant” may refer to an implant adapted to perform oneor more of: protecting the brain or spine; restoring or preventingdeformity; and providing anatomically-specific housing for embeddedneurotechnologies, and more importantly, is not limited to the“intercranial” space.

Cranial Embodiments

The act of brain surgery most often requires a craniotomy of significantsize. The majority (approximately 75%) of all craniotomies are donewithin the pterional region. Thus, the temporal anatomy may becomedistorted due to devascularization and deinnervation of the criticalstructures such as the temporalis muscle and temporal fat pad (i.e.,pertinent soft tissue). As such, facial symmetry may be foreverjeopardized and distorted following the breach of this anatomy. Inaddition, a significant number of neurosurgical patients may lose thebone flap (i.e., the segment of bone removed for access to the brain)due to either infection, tumor involvement, brain swelling, and/ortraumatic fracture. Therefore, a second surgery is required, known ascranioplasty, to reconstruct the missing cranial bone. Similarly, theact of spine surgery requires removal of some bone in order to accessthe spinal cord (i.e., laminectomy), which can also suffer frombone-related issues and needs improvement. For both the cranium andspine, the art and science of manmade alloplastic implants arose in the1990's but solely concentrated on replacing the missing bone withpatient-specific design. The present inventor had previously inventedthe first description of patient-specific craniofacial implants(described in U.S. Pat. No. 10,639,158, incorporated herein in itsentirety) to replace the missing soft tissue at the same time of skullreconstruction, by employing novel computer-assisted design algorithmsconcentrating on the above soft tissue. Most recently, the presentinventor had invented an improved design for which involvesbetter-defined anatomical vector lines for improved consistency (i.e.,enhanced results), a pre-fabricated temporal window to prevent softtissue impingement at time of placement, and the first-ever descriptionof placing these craniofacial implants above the scarred-down temporalismuscle as opposed to underneath it. However, the surgeon is limited inthese inventions by the fact that these “dual-purpose craniofacialimplants” (wherein the first purpose is to replace missing bone forbrain protection and the second purpose is to restore facial symmetrysecondary to soft tissue deformity) are delivered as one larger implant,as disclosed in Zhong et al., “Quantitative Analysis of Dual-Purpose,Patient-Specific Craniofacial Implants for Correction of CorporalDeformity”, the disclosure of which is incorporated herein in itsentirety.

First Embodiment

As shown in FIG. 1 , a first exemplary embodiment 100 offers the surgeona two-piece design with a standard cranial bone replacement implant 102,along with a small-, medium-, and large-sized soft tissue implantcomponent 104—which the surgeon can decide to use at time ofcranioplasty based on intraoperative assessment and degree of softtissue resorption. In the first exemplary embodiment 100,anatomy-specific craniofacial implants can be delivered as two separateimplants following virtual fusion/shape creation by way of CT scanningand CAD/CAM design including: a) a skull implant 102 designed to replacemissing cranial bone (i.e., pre-existing skull defect); and b) a softtissue implant 104 designed to replace missing temporalis muscle/fatwherein the fabrication process provides two implants to the surgeon anda lock-and-key (i.e., interdigitated) connection between the skullimplant 102 and the soft tissue implant 104 is utilized at time ofimplantation. The interdigitated connection may be designed, for exampleas a “male-like” piece (i.e., catheter system) that penetrates into thesoft side of a “female-shaped part” (i.e., fluid-filled chamber ofneuromedicine like chemotherapy). The connection may have a tight fit soas to make sure there is no fluid extravasation and/or loss ofelectricity between the hard and soft tissue reconstruction components.The soft tissue component may be delivered in small-, medium-, orlarge-sized dimensions to accommodate different degrees of expected softtissue resorption. An exemplary clinical scenario for such embodimentsmay be one where patients with pre-existing skull defects requireneuroplastic surgery

Second Embodiment

As shown in FIG. 2 , a second exemplary embodiment 200 offers thesurgeon an “anatomy-specific soft tissue implant” for neurosurgicalpatients. In instances as neurotechnology becomes refined and withsmaller footprints, it is conceivable that these functional devicescould be pre-designed to fill-in soft tissue elements around the brainor spinal cord, instead of needing to replace both bone and soft tissuefor placement. For example, a miniaturized implant one day could replacethe temporalis muscle and temporal fat pad, have a medicine deliverychamber inside with MRI-lucent-pump-assisted technology, and then haveminiaturized catheters connecting it through small skull holes into thebrain. Accordingly, such embodiments may present a less invasive optionfor all patients in need of such, and furthermore by brain tumorpatients that are in need of chronic infusion of brain tumor medicineand wishing to keep as much as their native skull as possible. Forexample, solid state batteries, RF charging advances, and rechargeablewireless batteries may make these devices much more miniaturized—andthus the smaller versions could be placed in areas filling only softtissue above; for example, so as to only fill in the atrophic temporalismuscle and/or fat pad areas after repeat craniotomy consistent withpost-neurosurgery temporal hollowing.

As such, a small-, medium-, and large-sized soft tissue implantcomponent 204 may be delivered to the surgeon based on pre-operative CTscan assessment—which the surgeon may decide to use at time ofcranioplasty based on intraoperative assessment and degree of softtissue deformity identified at time of exploration—dependent on the typeof central nervous system disease being treated and the size constraintsprovided by the implantable neurotechnology.

In the second exemplary embodiment 200, anatomy-specific craniofacialimplants may be delivered as one implant following virtual fusion/shapecreation by way of CT scanning and CAD/CAM design including: a) ananatomy-specific, soft tissue implant 204 with “high-profile” extensiondesigned to replace missing temporalis muscle/fat/subcutaneous tissue,wherein the fabrication process provides a lock-and-key (i.e.,interdigitated) connection for the soft tissue implant 204 to thehealthy cranial bone 201 at time of implantation. The soft tissuecomponent may be delivered in small-, medium-, or large-sized dimensionsto accommodate different degrees of expected soft tissue resorption. Anexemplary clinical scenario for such embodiments may be one wherepatients have pre-existing soft tissue defects following neurosurgicalcraniotomy defects requiring neuroplastic surgery.

Third Embodiment

As shown in FIG. 3 , a third exemplary embodiment 300 offers the surgeonan “anatomy-specific soft tissue implant” for neurosurgical patients inanticipation of future deformity. As such, a small-, medium-, andlarge-sized soft tissue implant component 304 may be delivered to thesurgeon based on pre-operative CT scan assessment—which the surgeon maydecide based on intraoperative assessment and degree of soft tissuemobilization identified at time of craniotomy.

In the third exemplary embodiment 300, anatomy-specific, multi-purposecraniofacial implants may be delivered as one implant following virtualfusion/shape creation by way of CT scanning and CAD/CAM designincluding: a) an anatomy-specific, soft tissue implant 304 designed toreplace missing temporalis muscle/fat/subcutaneous tissue, wherein thefabrication process provides a lock-and-key (i.e., interdigitated)connection for the soft tissue implant 304 to the healthy cranial bone301 at time of implantation. The soft tissue component may be deliveredin small-, medium-, or large-sized dimensions to accommodate differentdegrees of expected soft tissue resorption. The soft tissue implant maybe pre-embedded with life-changing or life-saving neurotechnologies(e.g., medicine delivery capabilities to bypass the blood-brain barrier)which may positively alter the function of the central nervous systemand nearby brain, such as electronic neuromodulation, chemicalmodulation with medicine delivery, optical imaging for brain assessment,fluid diversion for hydrocephalic disease, therapeutic neuromodulation,enhanced brain performance, chronic neurological disease treatment ofany kind, and/or improvement of memory storage. The soft tissuecomponent may be delivered in small-, medium-, or large-sized dimensionsto accommodate different degrees of expected soft tissue resorption. Anexemplary clinical scenario for such embodiments may be one wherepatients have non-existing soft tissue defects but need plannedneurosurgical craniotomy and neuroplastic surgery for instances likebrain tumor resection.

Fourth Embodiment

As shown in FIG. 4 , in a fourth exemplary embodiment 400, anotherindication for use of the novel dual-purpose implants as describedhereinabove, would be in instances of planned craniectomy (i.e.,elective removal of non-diseased or normal cranial bone). Manyneurosurgical procedures are planned on brain disease for which iscovered by normal, healthy bone (for patients who have never had surgeryin the targeted area and have undisrupted anatomy present). However, asthe field of neurotechnology continues to expand, the use of implantableneurotechnology will require elective removal of bone and soft tissue tomake room for these space-occupying devices for which can belife-changing or life-saving. For example, current day and futuristicdevices can deliver medicine for chronic neurological disease likecancer, epilepsy, neurodegenerative disease, post-traumatic stressdisorders (PTSD), attention-deficit hyperactivity disease (ADHD),movement tremor disease, memory deterioration, poor performance relatedto age, brain enhancement, stress-related environments, etc. Inaddition, these neurotech devices could house imaging devices to avoidnecessary CT scans or MRIs post-operatively. Such devices may also househydrocephalic shunting mechanisms and/or photoelectric neuromodulatorycomponents, with or without wireless charging platforms based on RFtechnology. Regardless of inherent function, such devices require spaceto avoid impingement on the underlying brain and subtle scalp above.Thus, this novel “dual-purpose implant” would have the anatomy-specificdesign to fit into each patient's exact dimensions for both the bone andsoft tissue being electively removed. Thus, the two-piece design—onebeing the skull implant 402 and the other being the soft tissue implant404 would be fitted together intraoperatively based on small, medium, orlarge-size expected soft tissue resorption assessed by the surgeon.Hence, such embodiments offer the surgeon a two-piece design with astandard cranial bone replacement implant 402, along with a small-,medium-, and large-sized soft tissue implant component 404—for which thesurgeon can decide to use at time of craniectomy based on intraoperativeassessment and degree of soft tissue resorption.

In the fourth exemplary embodiment 400, anatomy-specific craniofacialimplants can be delivered as two separate implants following virtualfusion/shape creation by way of CT scanning and CAD/CAM designincluding: a) a skull implant 402 designed to reconstruct/replace adefect for a planned craniectomy (i.e., elective removal of cranialbone; or non-existing skull defect); and b) a soft tissue implant 404designed to prophylactically restore (i.e., some degree of atrophy isexpected by the surgeon) temporalis muscle/fat, wherein the fabricationprocess provides two implants to the surgeon and a lock-and-key (i.e.,interdigitated) connection between the skull implant 402 and the softtissue implant 404 is utilized at time of implantation. The soft tissuecomponent could be delivered in small-, medium-, or large-sizeddimensions to accommodate different degrees of expected soft tissueresorption. An exemplary clinical scenario for such embodiments may beone where patients with non-existing skull defects require plannedcraniectomy and neuroplastic surgery.

Fifth and Sixth Embodiments

The brain is a complex organ which has no current substitute, as opposedto the human heart, lung, liver or kidney, as disclosed in Gordon, “TheSpecial Field of Neuroplastic Surgery” published in the Journal ofCraniofacial Surgery [2021 Jan.-Feb. 1; 32(1):3-7.(www.hopkinsmedicine.org/Neuroplastic-Surgery/about.html), thedisclosure of which is incorporated herein in its entirety. Thus, theonly way to manipulate the diseased or aging brain is to place awireless powered device which has the ability to alter brain function byway of medicine, electricity, neuroimaging, non-invasiveneuromodulation, and/or photooptics. Such devices have size constraintsdue to challenging craniofacial anatomy and require strategic placementwithin a biocompatible compartment. However, there is not much extraspace within the human head and within the cranial space. Strategically,the skull bone space is the ideal placement position—as disclosed inU.S. Pat. No. 11,058,541, “Low-profile Intercranial Device” (i.e.,“intercranial” referring to the space within the cranial bone). Thus,for patients who have pre-existing skull defects and are in need ofplaned cranioplasty reconstruction by way of neuroplastic surgery, theembodiments disclosed herein may provide an improved treatment strategy.However, for the purpose of brain medicine delivery via temporalimplants—based on pump-assisted, multiphase flow circuits, wirelesscharging platforms, embedded biosensors, and many other functionalcomponents—the skull space becomes heavily crowded and shown to be anon-viable option to the present inventor. First, a dual-purpose implantmay have a skull implant designed to replace missing cranioplasty bone(i.e., pre-existing defects), and, secondly, a soft tissue part may beprovided, which has an embedded functional component having, forexample, neurotechnologies for life-changing, life-saving, andbrain-altering capabilities. Of particular note, the cranial bone spaceof about 4-12 millimeters may not provide sufficient space for currentmedicine-delivery designs, especially as the technological applicationsfurther develop; thus, the embodiments disclosed herein are adapted tohouse embedded neurotechnologies within the overlying soft tissue part,as an anatomy-specific design (with a new thickness of about 13-40 mm byway of adding soft tissue, “extracranial” space). Additionally, thisextra extension up towards the skin (i.e., high-profile extension) mayallow better transcutaneous needle access, as in the case of chronicmedicine delivery and refillable reservoirs, and may allow for less softtissue interference when related to Bluetooth module/wireless RFcharging connectivity. Also, as a patient ages and their neurologicaldisease changes with respect to time, such a soft tissue part may beinterchanged in “plug-and-play” fashion, by decoupling the such from thecranial implant and installing a new soft tissue part. Within the softtissue aspect of this implant, a functional component may be embedded,and the functional component may include life-changing/life-savingneurotechnologies as well as provide swappable medicine chambers; suchtechnologies and medicines may positively alter the function of thecentral nervous system and nearby brain, such as: electronicneuromodulation, chemical modulation with medicine delivery, opticalimaging for brain assessment, fluid diversion for hydrocephalic disease,hands-free connectivity to wireless communication devices, prevention ofchronic symptoms, reversal of age deterioration, remote imaging devicesfor real-time, remote assessment, and/or improvement of memory storageand function. A similar design is applicable for spinal reconstructionas well, as disclosed in Gordon, et al., “First-in-human Experience withIntegration of a Hydrocephalus Shunt Device Within a Customized CranialImplant”; Featured Cover Image, Operative Neurosurgery; December 2019Issue, the disclosure of which is incorporated herein in its entirety.

As shown in FIG. 5 , in a fifth exemplary embodiment 500,anatomy-specific craniofacial implants may be delivered as two separateimplants following virtual fusion/shape creation by way of CT scanningand CAD/CAM design including: a) a skull implant 502 designed to replacemissing cranial bone (i.e., pre-existing skull defect); and b) a softtissue implant 504 designed to replace missing temporalismuscle/fat/subcutaneous tissue, wherein the fabrication process providestwo implants to the surgeon and a lock-and-key (i.e., interdigitated)connection between the skull implant 502 and the soft tissue implant 504is utilized at time of implantation; and wherein the soft tissue implant504 is embedded with a functional component 506 having, for example,life-changing or life-saving neurotechnologies which positively alterthe function of the central nervous system and nearby brain such aselectronic neuromodulation, chemical modulation with medicine delivery,optical imaging for brain assessment, fluid diversion for hydrocephalicdisease, therapeutic neuromodulation, chronic symptom reversal, functionenhancement, prevention of age-related deterioration, and/or improvememory storage. The soft tissue component 504 could be delivered insmall-, medium-, or large-sized dimensions to accommodate differentdegrees of expected soft tissue resorption. An exemplary clinicalscenario for such embodiments may be one where patients withpre-existing skull defects require neuroplastic surgery and placement ofan embedded functional component 506 strategically housed within softtissue component 504 to address an underlying neurological disease.

As shown in FIG. 6 , in a sixth exemplary embodiment 600,anatomy-specific craniofacial implants can be delivered as two separateimplants following virtual fusion/shape creation by way of anatomicalaveraging for standard sizes and/or CT scanning with CAD/CAM,patient-specific design including: a) a skull implant 602 designed toreplace bone following planned craniectomy (i.e., non-existing skulldefect); and b) a soft tissue implant 604 designed to replace missingtemporalis muscle/fat/subcutaneous tissue, wherein the fabricationprocess provides two implants to the surgeon and a lock-and-key (i.e.,interdigitated) connection between the skull implant 602 and the softtissue implant 604 is utilized at time of implantation; and wherein thesoft tissue implant 604 is embedded with a functional component 606having, for example, life-changing or life-saving neurotechnologieswhich may positively alter the function of the central nervous systemand nearby brain, such as: electronic neuromodulation, chemicalmodulation with medicine delivery, optical imaging for brain assessment,fluid diversion for hydrocephalic disease, therapeutic neuromodulation,and/or improvement of memory storage. The soft tissue component 604 maybe delivered in small-, medium-, or large-sized dimensions toaccommodate different degrees of expected soft tissue resorption. Anexemplary clinical scenario for such embodiments may be one wherepatients with non-existing skull defects in need of planned craniectomyand neuroplastic surgery require brain surgery and require placement ofan embedded functional component 606 housed within soft tissue implant604 to address an underlying neurological disease.

Spinal Embodiments Seventh and Eighth Embodiments

The act of spine surgery for cancer and/or trauma often requires someform of planned bone removal or decompression to make space for accessto the spinal cord. Most recently, novel technologies are being designedto alter impaired spinal cord function such as paralysis reversal,tremor, chronic pain, acute trauma, and/or weakness. Thus, theparaspinal anatomy (i.e., overlying muscle/fat) may inevitably becomedistorted at time of planned surgery due to devascularization anddeinnervation of critical structures such as the paraspinal musculature.As such, contour irregularities on the back and visual deformities maybe forever jeopardized following the breach of this critical anatomy.Unfortunately, the art and science of manmade alloplastic implants forcraniofacial and spinal reconstruction arose in the 1990's but solelyconcentrated on replacing the missing bone with patient-specific design.The present inventor had previously invented the first description ofpatient-specific craniofacial implants to replace the missing softtissue at the same time of skull reconstruction, by employing novelcomputer-assisted design algorithms. The present inventor had inventedan improved design for which involves better-defined anatomical vectorlines for improved consistency (i.e., enhanced results), apre-fabricated temporal window to prevent soft tissue impingement attime of placement, and the first-ever description of placing thesecraniofacial implants above the scarred-down temporalis muscle asopposed to underneath it. This was first described by the presentinventor in his sentinel article entitled “Temporal augmentation withmethyl methacrylate” in September 2011, as a way to use hand-shaped,alloplastic implants for simultaneous soft tissue and/or hard tissuedeformity correction using a primitive approach and hand-eyemodification. (Gordon, et al. Aesthetic Surgery Journal; 31(7):827-33.)However, the surgeon is also limited in these inventions by the factthat these “dual-purpose craniofacial implants” (wherein the firstpurpose is replacing missing bone for brain protection and the secondpurpose is restoring facial symmetry secondary to soft tissue deformity)are delivered as one larger implant, as disclosed in Zhong et. al.,“Quantitative Analysis of Dual-Purpose, Patient-Specific CraniofacialImplants for Correction of Corporal Deformity”, the disclosure of whichis incorporated herein in its entirety. Hence, the embodiments disclosedherein offer the spine surgeon a two-piece design with a standardvertebral bone replacement implant, such as a laminoplasty for example,along with a small-, medium-, and large-sized soft tissue implantcomponent—which the surgeon can decide to use at time of spine surgerybased on intraoperative assessment and degree of soft tissue resorption.

As shown in FIG. 7 , in a seventh exemplary embodiment 700,anatomy-specific spinal implants may be delivered as two separateimplants following virtual fusion/shape creation by way of CT scanningand CAD/CAM design including: a) a spinal bone implant 702 designed toreplace missing vertebral bone (i.e., pre-existing spinal defectfollowing previous spinal cord decompression surgery such aslaminectomy/laminoplasty and/or traumatic injury); and b) a soft tissueimplant 704 designed to replace missing paraspinal muscle/fat whereinthe fabrication process provides two implants to the surgeon and alock-and-key (i.e., interdigitated) connection between the spinal boneimplant 702 and the soft tissue implant 704 is utilized at time ofimplantation. The soft tissue component 704 may be delivered in small-,medium-, or large-sized dimensions to accommodate different degrees ofexpected soft tissue resorption. An exemplary clinical scenario for suchembodiments may be one where patients with pre-existing, post-operativespinal column defects require neuroplastic surgery.

As shown in FIG. 8 , in an eighth exemplary embodiment, anatomy-specificspinal implants may be delivered as two separate implants followingvirtual fusion/shape creation by way of CT scanning and CAD/CAM designincluding: a) a spinal bone implant 802 designed to replace plannedresection of vertebral bone (i.e., non-existing bone defect; plannedspinal cord decompression such as laminectomy/laminoplasty and/ortraumatic injury); and b) a soft tissue implant 804 designed to replacemissing paraspinal muscle/fat wherein the fabrication process providestwo implants to the surgeon and a lock-and-key (i.e., interdigitated)connection between the spinal bone implant 802 and the soft tissueimplant 804 is utilized at time of implantation. The soft tissuecomponent 804 may be delivered in small-, medium-, or large-sizeddimensions to accommodate different degrees of expected soft tissueresorption. An exemplary clinical scenario for such embodiments may beone where patients with non-existing defects require planned boneremoval, placement of embedded neurotechnology, and neuroplasticsurgery.

Further Spinal Embodiments

The spinal cord, as a component of the central nervous system, is acomplex organ for which has no current substitute, as opposed to thehuman heart, lung, liver or kidney, as disclosed in Gordon, “The SpecialField of Neuroplastic Surgery” published in the Journal of CraniofacialSurgery [2021 Jan.-Feb. 1; 32(1):3-7.,(www.hopkinsmedicine.org/Neuroplastic-Surgery/about.html), thedisclosure of which is incorporated herein in its entirety. Thus, theonly way to manipulate a diseased, traumatized and/or aging spinal cordis to place a device which has the ability to alter spinal cord functionby way of medicine, electricity, real-time, remote neuroimaging withwireless connectivity, non-invasive neuromodulation, and/or photooptics.Such devices have size constraints and require strategic placementwithin a biocompatible compartment. However, there is not much extraspace within the human spine and back. Strategically, the bone spaceabove the brain and spinal cord is therefore the ideal placementposition—as disclosed in U.S. Pat. No. 11,058,541, “Low-profileIntercranial Device”—but the present inventor has realized that medicinedelivery technology needs more than just “bone-only” volume. However, asthe temporal multipurpose devices become more miniaturized over severaliterations, the soft tissue space may allow for placement of a two-piecedesign implant, thereby removing the severity of surgery when“plug-and-play” switching is needed, and minimizing the need for boneremoval altogether.

Ninth and Tenth Embodiments

Thus, for patients who have pre-existing spine defects from previoussurgeries and are in need of planned reconstruction by way ofneuroplastic surgery, such embodiments may provide an improved treatmentstrategy. First, a dual-purpose implant may have a spinal implantdesigned to replace missing vertebral bone (i.e., pre-existing defects),and, second, a soft tissue implant may be provided which may include afunctional component having embedded neurotechnologies forlife-changing/life-saving, spinal cord-altering capabilities. Ofparticular note, the vertebral bone space is just a few millimeters andis often not enough space for current designs; thus, the embodimentsdisclosed herein can house embedded neurotechnologies within the softtissue implant space. Furthermore, as one ages and their neurologicaldisease changes with respect to time, the soft tissue implant may beinterchanged in a “plug-and-play” fashion, for example by decoupling itfrom the spinal implant and using a new soft tissue implant. Within thesoft tissue aspect of the implant, a functional component having, forexample, life-changing/life-saving neurotechnologies may be embedded,which may positively alter the function of the central nervous systemand nearby spinal cord, such as: electronic neuromodulation, chemicalmodulation with medicine delivery, real-time, remote optical imaging forblood flow assessment with wireless connectivity, fluid diversion fortrauma or disease, improvement of paralysis, fluid diversion forhydrocephalic disease, hands-free connectivity to wireless communicationdevices for patient provider interpretation, reversal of paralysis,and/or improvement of strength/balance. Of note, in instances ofimplantable neurotechnology devices becoming more refined with smallerfootprints over time, it is conceivable that these functional devicescould be pre-designed to fill-in soft tissue elements around the brainor spinal cord, instead of needing to replace both bone and soft tissuefor placement. For example, solid state batteries and rechargeablewireless platforms with radio signals (i.e., RF technology) may makethese devices more miniaturized—and thus the smaller versions could beplaced in areas filling only soft tissue above. This would mean thatswitching the outer piece for a different, disease-specific technologymay be less invasive since the bone space would not be invaded duringrepeat surgery.

As shown in FIG. 9 , In a ninth exemplary embodiment 900,anatomy-specific spinal implants may be delivered as two separateimplants following virtual fusion/shape creation by way of CT scanningand CAD/CAM design including: a) a spinal bone implant 902 designed toreplace vertebral bone following planned decompression (i.e.non-existing spine defect); and b) a soft tissue implant 904 designed toreplace missing paraspinal muscle/fat/subcutaneous tissue, wherein thefabrication process provides two implants to the surgeon and alock-and-key (i.e., interdigitated) connection between the spinal boneimplant 902 and the soft tissue implant 904 is utilized at time ofimplantation; and wherein the soft tissue implant 904 includes afunctional component 906, which may, for example, include life-changingor life-saving neurotechnologies which positively alter the function ofthe central nervous system and nearby spinal cord such as electronicneuromodulation, chemical modulation with medicine delivery, opticalimaging for brain assessment, fluid diversion for hydrocephalic disease,therapeutic neuromodulation, prevention of age deterioration,performance enhancement for sports, and/or improvement of memorystorage. The soft tissue component 904 may be delivered in small-,medium-, or large-sized dimensions so as to accommodate differentdegrees of expected soft tissue resorption. An exemplary clinicalscenario for such embodiments may be one where patients withpre-existing spinal column defects require neuroplastic surgery andplacement of an embedded neurotechnology device 906 strategically housedwithin the soft tissue implant 904 to address an underlying spinal corddisease. Not having to go into the bone space greatly lessens theinvasiveness of future surgeries as the outer component gets switchedout—for instances like medicine chamber refills, battery exchange,hardware updates, or change is neurological disease and updatingcorresponding applications of relevance.

As shown in FIG. 10 , in a tenth exemplary embodiment 1000,anatomy-specific spinal implants may be delivered as one implantfollowing virtual fusion/shape creation by way of CT scanning andCAD/CAM design, including: a) an anatomy-specific, soft tissue implant1004 designed to replace missing paraspinal muscle/fat, wherein thefabrication process provides a lock-and-key (i.e., interdigitated)connection for the soft tissue implant 1004 to the healthy vertebralbone 1001 at time of implantation. The soft tissue component 1004 may bedelivered in small-, medium-, or large-sized dimensions so as toaccommodate different degrees of expected soft tissue resorption. Anexemplary clinical scenario for such embodiments may be one wherepatients with pre-existing soft tissue defects following previous spinesurgery require neuroplastic surgery and placement of an embeddedneurotechnology device strategically housed within soft tissue implant1004 to address an underlying spinal cord disease.

Eleventh Embodiment

As shown in FIG. 11 , in an eleventh exemplary embodiment 1100, forpatients who require some form of planned decompression and/or implantedneurotech device, such embodiments may provide improved treatmentstrategy. First, a dual-purpose implant 1100 may have a bone implant1102 designed to replace missing vertebral bone (i.e., pre-existingdefects), and, second, a soft tissue implant 1104 may be provided whichmay include an embedded functional component 1106 having, for example,neurotechnologies for life-changing/life-saving, spinal cord-alteringcapabilities. Of particular note, the vertebral bone space is just a fewmillimeters and is often not enough space for current designs; thus, theembodiments disclosed herein can house embedded neurotechnologies withinthe soft tissue implant space. Furthermore, as one ages and theirneurological disease changes with respect to time, the soft tissueimplant 1104 may be interchanged in a “plug-and-play” fashion, forexample by decoupling it from spinal bone implant 1102 and using a newsoft tissue implant 1104. Within the soft tissue aspect of the implant1104, a functional component 1106 may be embedded, which may positivelyalter the function of the central nervous system and nearby spinal cord,such as: electronic neuromodulation, chemical modulation with medicinedelivery, optical imaging for blood flow assessment, fluid diversion fortrauma, prevention of age-related deterioration, performanceenhancement, resolution of chronic disease, reversal of lower/upperextremity paralysis, fluid diversion for hydrocephalic disease,hands-free connectivity to wireless communication devices, reversal ofparalysis, and/or improvement of strength/balance.

In the eleventh exemplary embodiment 1100, anatomy-specific spinalimplants may be delivered as two separate implants following virtualfusion/shape creation by way of CT scanning and CAD/CAM designincluding: a) a spinal bone implant 1102 designed to replace vertebralbone following planned decompression (i.e., non-existing spine defect);and b) a soft tissue implant 1104 designed to replace missing paraspinalmuscle/fat/subcutaneous tissue, wherein the fabrication process providestwo implants to the surgeon and a lock-and-key (i.e., interdigitated)connection between the spinal bone implant 1102 and the soft tissueimplant 1104 is utilized at time of implantation; and wherein the softtissue implant 1104 is embedded with a functional component 1106 having,for example, life-changing or life-saving neurotechnologies whichpositively alter the function of the central nervous system and nearbyspinal cord such as electronic neuromodulation, chemical modulation withmedicine delivery, optical imaging for brain assessment, fluid diversionfor hydrocephalic disease, therapeutic neuromodulation, prosthetic limbcontrol, and/or improvement of memory storage. The soft tissue component1104 may be delivered in small-, medium-, or large-sized dimensions soas to accommodate different degrees of expected soft tissue resorption.An exemplary clinical scenario for such embodiments may be one wherepatients with non-existing spinal column defects (i.e., planned surgery)require neuroplastic surgery and placement of an embedded functionalcomponent 1106 strategically housed within soft tissue implant 1104 toaddress an underlying spinal cord disease.

Twelfth Embodiment

As shown in FIG. 12 , in a twelfth exemplary embodiment 1200, forpatients in need of planned spinal cord surgery and reconstruction byway of neuroplastic surgery, such embodiments may provide an improvedtreatment strategy via neuroplastic surgery. As implantableneurotechnology devices becoming more refined with smallerfootprints—for the purpose of embedding within “anatomy-specificimplant” encasements, it is conceivable that these functional devicescould be pre-designed to fill-in soft tissue elements around the spinalcord, instead of needing to replace both bone and soft tissue forplacement. For example, pump-assisted delivery systems with medicine,solid state batteries and rechargeable wireless platforms (i.e., RFtechnology) with radio signals may make these devices much moreminiaturized—and thus the smaller versions could be placed in areasfilling only soft tissue above the spine, like within the paraspinalmusculature. This would mean that switching the outer piece for adifferent, disease-specific technology may be less invasive since thebone space would not be invaded during repeat surgery. Furthermore, asone ages and their neurological disease changes with respect to time,the soft tissue implant 1204 may be interchanged in a “plug-and-play”fashion, for example by decoupling it from healthy vertebral bone 1201and using a new soft tissue implant 1204. Within the soft tissue aspectof the implant 1204, a functional component 1206 having, for example,life-changing/life-saving neurotechnologies may be embedded, which maypositively alter the function of the central nervous system and nearbyspinal cord, such as: electronic neuromodulation, chemical modulationwith medicine delivery, optical imaging for blood flow assessment, fluiddiversion for trauma or disease, improvement of paralysis, fluiddiversion for hydrocephalic disease, hands-free connectivity to wirelesscommunication devices, reversal of paralysis, and/or improvement ofstrength/balance.

In the twelfth embodiment 1200, anatomy-specific spinal implants may bedelivered as one implant following virtual fusion/shape creation by wayof CT scanning and CAD/CAM design, including: a) an anatomy-specific,soft tissue implant 1202 designed to replace missing paraspinalmuscle/fat/subcutaneous tissue, wherein the fabrication process providesa lock-and-key (i.e., interdigitated) connection for the soft tissueimplant 1202 to the healthy vertebral bone 1201 at time of implantation.The soft tissue component 1202 may be delivered in small-, medium-, orlarge-sized dimensions to accommodate different degrees of expected softtissue resorption. This soft tissue implant 1202 may be embedded with afunctional component 1206 having, for example, life-changing orlife-saving neurotechnologies which may positively alter the function ofthe central nervous system and nearby spinal cord such as electronicneuromodulation, chemical modulation with medicine delivery, opticalimaging for brain assessment, fluid diversion for hydrocephalic disease,therapeutic neuromodulation, and/or improvement of memory storage. Thesoft tissue functional component 1206 may be delivered in small-,medium-, or large-sized dimensions to accommodate different degrees ofexpected soft tissue resorption. An exemplary clinical scenario for suchembodiments may be one where patients with non-existing soft tissuedefects in need of planned spine surgery require neuroplastic surgeryand placement of an embedded neurotechnology device strategically housedwithin the soft tissue implant 1204 so as to address an underlyingspinal cord disease.

It should be appreciated that the embodiments disclosed herein mayfurther be modified without departing from the spirit of the invention.In some embodiments, rather than a lock-and-key fit, the bone implantand soft tissue implant may be fused during the fabrication process or“click-in” using a plug or adapter, designed for intra-operativemanipulation, or may include a switch for post-operative manipulation.The embedded neurotechnologies may further include, but are not limitedto, any technology capable of or adapted to brain or spine modulation,for example to deliver medicine, control disease, remove or curedysfunction, restore traumatized brain or spinal cord, or to improve orsuperficially augment the aging central nervous system with external,wireless connections. Some such neurotechnologies are shown in FIG. 14 .Furthermore, in some embodiments, soft-tissue-only dual-purpose implantsmay include a small catheter, filament or wire passed through the boneinto the brain or spinal cord, so as to allow wireless connectivity tothe external world and/or to deliver pump-assisted, connection-enhanceddelivery for bypassing the blood-brain barrier.

Furthermore, in some embodiments, the implants may be constructed of anymaterials that enable them to function as described herein, for examplevarious man-made biomaterials and/or 3D printed tissue. The biomaterialsmay furthermore be radiolucent, for unimpeded wireless connectivity suchas Bluetooth, sonolucent, for unimpeded sonography (both diagnostic andtherapeutic), and visually clear, for improved surgery placementaccuracy including bleeding inspection and reducing the likelihood ofimpingement on the brain or spinal cord underneath during fixation withhardware. More than one spinal or cranial implant may be used, forexample, coupled to several vertebrae or a as bilateral cranial implant.

Functional Component Embodiment

FIG. 13 shows an exemplary functional component 1300 which may be usedwith the embodiments of the implants described hereinabove. Thefunctional component can be sized and shaped to fit within the temporalfossa, and further within embodiments of the soft tissue implantdescribed herein. The functional component 1300 may include a housing1302, one or more electronic components 1304, which may include acentral processing unit 1306 and a rechargeable battery 1308. Thefunctional component 1300 may further include a refillable reservoir1310 having a cover or diaphragm 1312 that may be penetrable by apercutaneous or similar needle. The functional component 1300 mayfurther include a plurality of conduits or catheters 1314, for examplefive catheters that may have length such that they can penetratesubdurally approximately 2-5 centimeters deep into the brain. Additionalelectronic components disposed within functional component 1300 mayinclude, but are not limited to, a Bluetooth module 1316, at least oneelectro-osmotic pump 1318, Furthermore, rechargeable battery 1308 mayutilize wireless charging so as to be able to charge from a distance,for example up to 18 inches away from functional component 1300 (i.e.,the charging portion may be placed under a pillow or within thepillowcase of the patient needing device-charging overnight, or within aheadwear having internal components to allow charging during thedaytime).

Furthermore, the cover or diaphragm 1312 may protrude above thesurrounding surface of housing 1302, such that the diaphragm and“high-profile” design may be easily palpable under the skin to improvesafety and efficacy of needle filling. It should be appreciated thatthis is in contrast to a “low-profile” intercranial design, wherein thefunctional component would have a smooth contour with normal bone allaround, and therefore not be palpable by one's fingers rubbing along theskin's surface, and presenting an impediment to percutaneous refillingof a reservoir. The present functional component 1300, however, extendswithin the soft tissue implant, and therefore allows, for example,digital palpating prior to refilling with a percutaneous needle byhaving a palpable ring structure surrounding the self-sealing diaphragm.

Furthermore, the cover or Bluetooth module/wireless RF charging platform1316 may protrude above the surrounding surface of housing 1302, suchthat the diaphragm and “high-profile” design may be easily palpableunder the skin to improve safety and efficacy of wireless connectivity.It should be appreciated that this is in contrast to a “low-profile”intercranial design, wherein the functional component would have asmooth contour with normal bone all around, and would have a fully thickscalp and soft tissue element covering it, and therefore presenting animpediment to wireless charging and/or Bluetooth connectivity. Thepresent functional component 1300, however, extends within the softtissue implant, and therefore allows, for example, more effective andsafer wireless communication and/or charging.

According to the embodiments disclosed herein, FIG. 14 shows a hardtissue implant 1402 and soft tissue implant 1404, coupled to a skull 14.A functional component 1406 is disposed within soft tissue implant 1404.Shown as part of the functional component 1406 are a diaphragm 1412, twoMRI-lucent electro-osmotic pumps 1418, and a plurality of catheters 1414which extend from functional component 1406 into brain tissue 16 so asto enable the delivery of desired substances into the brain tissue.While not shown in FIG. 14 , functional component 1406 may include allcomponents described above with respect to functional component 1300.

Additionally, a rechargeable battery of functional component 1406 may becharged by a wireless charging device 1430, which may be located withinor under a pillow 18 of a patient. A Bluetooth or other wirelesscommunication component of functional component 1406 may further be incommunication with software 1440 executed on a mobile computing deviceor personal computing device 20. The software 1440 may be adapted toshow real-time data from functional component 1406. Real-time data, suchas flow rate information, residual battery life, medicine reservoir fillamounts, and potential flow malfunction, could all be transferred inreal-time. In addition, the current design algorithm for this medicinedelivery device includes an alternating rhythm of 16-20 hours pump-on,followed by alternating brain relaxation times of 4-8 hours off.

Furthermore, in some exemplary embodiments, both the bone implant andthe soft tissue implant may include cavities therein for embeddedfunctional devices, similar to the embodiments described above.

The foregoing description and accompanying figures illustrate theprinciples, preferred embodiments and modes of operation of theinvention. However, the invention should not be construed as beinglimited to the particular embodiments discussed above. Additionalvariations of the embodiments discussed above will be appreciated bythose skilled in the art.

Therefore, the above-described embodiments should be regarded asillustrative rather than restrictive. Accordingly, it should beappreciated that variations to those embodiments can be made by thoseskilled in the art without departing from the scope of the invention asdefined by the following claims.

What is claimed is:
 1. An anatomy-specific implant, comprising: a boneimplant adapted to replace missing bone or healthy bone in need ofremoval; and a soft tissue implant adapted to replace missing softtissue and occupy a soft tissue space around the bone replaced by thebone implant, the soft tissue implant being coupled to the bone implant;wherein a functional component is embedded within an interior space of abody of the soft tissue implant, and the functional component comprisesat least one catheter for delivery of medicine, and wherein the boneimplant and soft tissue implant are anatomy-specific and notpatient-specific.
 2. The implant of claim 1, wherein the bone implant isa spinal bone implant or an orthopedic joint bone implant.
 3. Theimplant of claim 2, wherein the functional component is configured formedicine infusion in spine or orthopedic joint areas.
 4. The implant ofclaim 3, wherein the orthopedic joint areas comprise a hip, knee,shoulder and ankle.
 5. The implant of claim 3, wherein the medicinecomprises chronic pain medicine and/or cancer treatment medicine.
 6. Theimplant of claim 1, wherein the soft tissue comprises one ofsmall-sized, medium-sized, and large-sized dimensions to accommodatedifferent degrees of expected soft tissue resorption.
 7. The implant ofclaim 1, wherein the soft tissue is configured to replace at least oneof missing muscle, fat, or subcutaneous tissue around the bone.
 8. Theimplant of claim 1, wherein the soft tissue implant is coupled to thebone implant by a lock- and key connection.
 9. The implant of claim 1,wherein the functional component comprises a housing, a refillablereservoir, and at least one electro-osmotic pump.
 10. The implant ofclaim 9, wherein a diaphragm of the reservoir protrudes above a surfaceof the housing.
 11. The implant of claim 9, further comprising aprocessor, a wirelessly rechargeable battery, and a wirelesscommunications device.
 12. The implant of claim 1, wherein the softtissue implant is interchangeable with another soft tissue implant in aplug-and-play fashion.
 13. The implant of claim 1, wherein thefunctional component is further configured to remove or curedysfunction, restore traumatized spinal cord, or to improve orsuperficially augment the aging central nervous system with external,wireless connections.